Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
- Company
- Boston Scientific Corporation
- Recall Initiated
- August 28, 2025
- Posted
- September 23, 2025
- Recall Number
- Z-2618-2025
- Quantity
- 156 units
- Firm Location
- Marlborough, MA
Reason for Recall
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Distribution
US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.
Lot / Code Info
Instructions for Use: 51878205; Pre-Printed Ouch: 51368417; 1. UPN (REF): M00547030 (9-12mm Below); UDI-DI: 08714729790280; Lot Numbers: 36398057; 2. UPN (REF): (1) M00547000(9-12mm Above); UDI-DI: 08714729790266; Lot Numbers: 36426495;
Root Cause
Process control
Action Taken
On August 28, 2025 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Instructions: 1. Immediately cease further distribution or use of any remaining affected devices. Segregate the units in a secure place until they can be returned. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. 4. Return affected devices.